MR FEATURES
Cuban Studies Aim
for National
CKD Prevention
By Gail A. Reed
Extrapolating from racial, ethnic and social data of kidney patients in the USA, there is no doubt that the Caribbean and Central America are sitting on a CKD volcano, as our Editorial suggests. The acute problems of cost to health systems and to patients, and of patient accessibility to the latest pharmaceuticals and to renal replacement therapy itself, loom still larger in these resource-poor settings.
At the groundbreaking March 2004 meeting of the ISN’s Commission for the Global Advancement of Nephrology (COMGAN) at the Bellagio Study Center in Italy – “Preventing the Progression of Kidney Disease: Toward Global Equity” - generating knowledge for prevention in developing countries was identified as an urgent imperative.[1]
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On the Isle of Youth, a family doctor tests patient’s urine sample following informed consent to participate in the study.
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“There is a clear need to develop and extend local clinical and epidemiologic research programs in developing countries which will result in acquisition of knowledge required to succeed in implementing preventive medicine programs,” write nine of the participants on behalf of the ISN-COMGAN Bellagio Study Group 2004.[2]
Such population-based research, leading to evidence-based public health practice, is the objective of three concurrent studies under way in Cuba.
“The studies represent a more developed stage in our emphasis on prevention, which has been a priority for us since the 1980’s,” notes Dr. Raúl Herrera Valdés, Director of the national Institute of Nephrology, a leading force in the three research projects.
Dr. Miguel Almaguer, head of the Institute’s Epidemiology Department, referred to earlier studies among samples in Pinar del Río, Camagüey, Cienfuegos and Santiago de Cuba Provinces, leading to the adoption of national prevention strategies in 1996. “But we realized we had to go deeper, and began designing the new set of research,” notes Dr. Almaguer, explaining that the team also received encouragement from Dr. Barry Brenner of Harvard, widely recognized as a world leader in preventive nephrology, during a visit to the island.
Dr. Herrera told MEDICC Review that the studies aim to identify, diagnose and study the behavior of CKD in different Cuban populations; and then, combining these results with the international experience and recommendations, formulate primary and secondary prevention strategies that can be effectively implemented by the health system nationally. He emphasized that the three studies pursue similar aims, their more specific objectives and outcomes expected to both reinforce and inform one another in the pursuit of such a nationally applied prevention program.
“The studies are expected to reinforce and inform one another in pursuit of a nationally applied prevention program.”
—Dr. Raúl Herrera |
On the ethical side, says Dr. Herrera, “it is important for us to guarantee access to nephrology services and renal replacement therapies for each new patient identified through the studies. In this regard, the extension of dialysis from 31 to 47 centers around the country, has offered us the backup we need.” (See Spotlight, this issue.)
The Studies
The Isle of Youth Study (ISYS): a longitudinal study in total population(80,721), expected to last decades, aspires to become the “Framingham of CKD” as Dr. Almaguer put it. The study contemplates the family as the essential unit for research.
Phase I, involving community-based mass screening for markers of renal damage, began on November 1, 2004; by May, 2005, individual patient questionnaires, interviews and initial urine tests were expected to be completed, including those on newborns.[3]
Early results show a 17-20% range for risk markers, according to Dr. Rafael Aguilera Copello, chief nephrologist on the Isle. “These are consistent with what we are also seeing in the Havana-Cerro study,” he told MEDICC Review.
Over the years, because of migration patterns to the southerly Isle of Youth, it has become a “genetic mosaic” of the Cuban mainland, reiterating its potential as an epidemiological guide, notes Dr. Aguilera Copello, local coordinator of the study. “The Isle of Youth,” comments Dr. Herrera, “also has the geographic and population proportions of many other island nations of the Caribbean, and thus the results of our research may be of particular importance to them as well.”
The study involves the Isle’s 113 family doctor-and-nurse teams, three polyclinics and municipal hospital (with nephrology services), which provide universal coverage there. The research is designed to:
- Identify main demographic and risk factors for chronic renal insufficiency and other chronic illnesses sharing vascular damage as a common denominator;
- Track these risk factors and patients over time;
- Identify persons with any degree of kidney dysfunction (through laboratory testing of the whole population, including proteinuria, hematuria, microalbu-minuria, and serum creatinine);
- Track these persons over time, applying secondary preventive measures to slow the progress of their disease;
- Formulate and apply primary preventive strategies for those patients identified as healthy;
- Analyze the results of all stages of the study, and present the conclusions to national and international experts in the field.
At various stages, the study will branch out, to more profoundly examine areas of concern such as the relationship between CKD and cardiovascular or cerebrovascular disease, diabetes mellitus, hypertension, etc.
The Havana-Cerro Study: research among patients in the Cerro Municipality of the capital (total pop. 131,327) identified with risk factors for the development of CKD - some 30,000 persons. [4] The most immediate outcome of the study will be recommendations for comprehensive prevention and care models for such patients - commencing at the community level - to be piloted in Cerro. Leading the investigation is municipal health department director, Dr. Yamila de Armas, specialist in Family Medicine. She is joined by the 190 family doctors and nurses, four polyclinics and the Salvador Allende Teaching Hospital, which offer complete coverage to the population.
The study was begun in September, 2004 with the training of personnel; patient questionnaires, interviews and urine analyses were started in January, 2005, to be completed in the coming months. The key, notes Dr. de Armas, “is to design models of attention for these at-risk persons, from the family doctor on up to the tertiary level. We are looking at the way the patients flow through the system, building prevention into each level and each stage of illness, paying close attention to quality of care.”
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Drs. Rafael Aguilera Copello, Miguel Almaguer, Yamila de Armas and Raúl Herrera working on integrating the three investigations.
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“Our whole health system,” she emphasizes, “must be better organized around what our patients are getting sick from and what they are dying from; around this epidemiological evidence base. We are working to organize it logically, from the moment the patient enters the system - assessing what that patient requires at each level in terms of answers, resources and staff competencies. This study is invaluable because it synergizes this whole process, by giving us a concrete place to start.”
The Pinar del Río Study: research carried out in two of this westernmost province’s municipalities - Pinar del Río City and San Cristóbal - among approximately 43,000 persons identifiedwith risk factors for the development of CKD. Part of the value added to this investigation resides in the difference between thetwo cohorts included - one located in an urban provincial capital, the other in a smaller, semi-rural mountainous area (for more on San Cristóbal, see Bringing Services Closer to Home: MR Visits a New Dialysis Center in Cuba,this issue). Thus, results will offer additional comparative data to help complete the national picture of CKD, its risk factors and their relationship to genetic, environmental and other influences, as well as to other diseases rooted in vascular damage.
In addition, it is expected that initial epidemiological results from all three studies, particularly informed by the in-depth work on models of prevention-oriented care being formulated and piloted as part of the Havana-Cerro study, will allow Pinar del Río to be the first province to “scale up” the Cerro experience. The longer-range goal is to adapt and apply the models throughout the health system nationally.
The Pinar del Río study is now in the preparatory phase, under the leadership of provincial director of nephrology services, Dr. Leonel Soto, and testing is expected to begin before June 2005.
Prevention:
From Watchword to System-wide Practice
The studies aim for a precise characterization of the CKD epidemic in Cuba, with a more profound analysis of risk factors, both those known up to now and those that may be newly identified, “a first important step in public health policy planning,” notes Dr. Almaguer. Second, their results will inform the design of comprehensive models of education, prevention, and treatment at all levels of care. And third, it is expected that these models will be piloted, adapted and extended to the health care system as a whole. “This application in practical terms should become our most important contribution,” he says.
“We also hope this comprehensive approach will be a contribution to teaching, research, treatment and - above all - prevention in the region, says Dr. Herrera. “We believe that CKD can be used as a tracer, guiding prevention of other chronic conditions which have in common the same physiological mechanism of vascular damage. Preventive strategies designed and implemented for CKD should give us a vital head start on other critical health problems beginning to seriously burden developing countries like ours, including diabetes, hypertension, cardiovascular and cerebrovascular disease.”
References and Notes
- International Society of Nephrology Calls for a Global Fund to Fight Kidney Disease, ISN Press Release, Brussels, March 15, 2004. http://www.isn-online.org/site/cms/contentviewarticle.asp?article=2094.
- Correa-Rotter R, Naicker S, Katz IJ, Agarwal, SK, Herrera Valdes H, Kaseje D, Rodriguez-Iturbe B, Shaheen F, Sitthi-Amorn C: Demographic and epidemiologic transition in the developing world: Role of albuminuria in the early diagnosis and prevention of renal and cardiovascular disease. Kidney Int 66:S32-S37, 2004.
- Dipstick urinalysis was performed initially on all participants, regarding as abnormal results of proteinuria >1+ and hematuria >1+. If test was negative for proteinuria and hematuria, then microalbuminuria dipstick urinalysis was performed in risk groups - including those with diabetes mellitus, hypertension, low birthweight antecedent, CKD family history, cardiovascular disease antecedent, pregnancy, obesity, renal disease antecedent, and in children <5 years or persons >60 years. Considered abnormal were results of microalbuminuria >20 mg/L. All positive results for proteinuria, hematuria, or microalbuminuria are being studied for serum creatinine levels.
- The same definition of “at-risk populations” was used as for the ISYS study (see [3] above).
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